Web30 Nov 2024 · The aim of the EMA CTIS Sponsor Handbook (‘Handbook’) is to provide clinical trial (CT) sponsors representing pharmaceutical industry, SME (small and medium … Web10 Aug 2024 · 10th August 2024. The EMA Clinical Trial Information System (CTIS) Sponsor Handbook is now available on the EMA website. The handbook provides clinical trial …
CTIS Sponsor Admin role available into EMA IAM Platform today
Webfor CTIS authority workspace users v1.0.2.0 (PDF, in English) Release notes January 2024 This document outlines the latest updates to the CTIS system, including the secure Sponsor and Authority workspaces, and to the Clinical Trials website. WebThe sponsor workspace in the Clinical Trials Information System (CTIS) assists clinical trial sponsors and other organisations involved in running clinical trials in preparing and … dgm safety \u0026 security spain sl
Clinical Trials Information System (CTIS) List of known issues for ...
WebThe purpose of this document is to describe issues known to occur in the sponsor workspace of CTIS. These issues have been identified mainly through use of the CTIS test … WebFor a national clinical trial, the reporting Member State (rMS) is the MS to which the clinical trial application is submitted. For multinational trials, the sponsor proposes a rMS but it is up to the MSc to express their willingness to become rMS during the first 3 … WebThe European Medicines Agency (EMA) has published a new handbook helping sponsors prepare themselves for using CTIS, which is aimed at pharmaceutical companies, contract research organisations (CROs), small and medium-sized enterprises (SMEs), academic sponsors and any other organisations involved with clinical trials. dgm safety \u0026 security spain